New Delhi, June 26 : The Union Health Ministry has released a draft notification proposing a significant change in regulations governing imported medicines, mandating that all pharmaceutical products entering India must carry a minimum remaining shelf life of 12 months at the time of import.
The proposal, issued for public consultation through a gazette notification dated June 22, seeks to amend existing provisions under the Drugs Rules. At present, imported medicines are required to have a residual shelf life exceeding 60 per cent of their total validity period. The new draft suggests replacing this criterion with a fixed minimum standard of one year.
Officials stated that the objective of the proposed reform is to ensure that patients receive medicines that retain adequate usability throughout their distribution and consumption cycle. By guaranteeing a longer remaining shelf life, the government aims to strengthen the reliability and efficiency of pharmaceutical supply chains across the country.
The ministry emphasised that the revised framework is intended to reduce wastage caused by short-dated imports. Medicines with limited validity often risk expiring before reaching end users, resulting in financial losses and supply constraints. The proposed rule is expected to address these challenges by allowing more time for storage, distribution and utilisation.
However, the draft notification also clarifies that certain categories of medicines will remain exempt from the revised requirement. Biological products and radiopharmaceuticals will continue to follow the existing rule of a minimum residual shelf life of more than 60 per cent, considering their specialised nature and handling requirements.
According to officials, the change is designed to balance patient safety with logistical efficiency. While ensuring adequate shelf life for general pharmaceuticals, the government has maintained separate provisions for sensitive medical categories where stricter handling norms already apply.
The ministry further clarified that the amendment does not alter any other regulatory provisions under the Drugs and Cosmetics Act, 1940, or the Drugs Rules, 1945. Standards related to quality, safety and efficacy of medicines will continue to remain fully in force.
Authorities believe the revised shelf-life requirement will help optimise inventory management across the healthcare system. By reducing the risk of medicines expiring during transit or storage, the policy is expected to improve availability of essential drugs in both urban and rural markets.
The proposal is also projected to lower overall healthcare costs by minimising wastage and improving procurement efficiency. A longer residual shelf life is expected to give distributors and healthcare providers greater flexibility in managing stocks.
The Health Ministry has invited objections and suggestions from stakeholders as part of the consultation process before finalising the amendment. Industry participants, healthcare professionals and public health experts are expected to review the draft and provide feedback.
If implemented, the new rule would mark a notable shift in India’s pharmaceutical import regulations, aligning supply chain practices with broader goals of efficiency, affordability and patient-centric healthcare delivery.